The Food Safety and Standards Act. 2006 has come into force with effect from 05^th August. 2011. It defines a Food Business Operator (FBO) as a person engaged in the business of food manufacture, processing, packaging, transportation, distribution, storage and import etc. and includes food services, catering services and sale of food or food ingredients.

REGISTRATION AND LICENSING

• All Food Business Operators (FBO) in the country have to be registered or licensed in accordance with the cutoff limits laid down in the Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011.
• A milk producer whose production capacity of the Milk & Meat Products is less than 100 Kg/Ltr. per day, or is handling milk less than 500 Ltr. per day, meat or meat products producer in the capacity for slaughter of maximum 2 large animal or 10 small animals or 50 poultry birds per day or any other FBO where annual turnover is less than Rs 12 Lakh is termed as Petty Food Business Operator (PFBO) and is required to be registered.
• Schedule 1 of the Regulations defines the businesses that will be licensed by FSSAI Regional offices. All other businesses will have to obtain license from the local District Designated Officer of the state.
• Application can be filed online at foodlicensing.fssai.gov.in for central licensing.

EXISTING LICENSEES

■                    Convert your existing food licenses / registration into FSSAI license Registration before 5^th August, 2012

■                    No license registration fee will have to be paid for the remaining period of the validity of the earlier license or registration.

■                    All FBO should have valid license at all time.

• If the existing license registration has expired after 5″ August. 2012 apply for its renewal immediately.

■                    No pre – inspection required.

■                    A New FSSAI license number will be issued.

• Comply with existing provisions of Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011.

For further details visit fssai.gov.in or Dial-Toll free helpline 1800112100

Issued in Public interest by

Food Safety and Standards Authority of India

FDA Bhawan, Kotla Road,

New Delhi – 110002

Endogenous Cushing’s syndrome is a serious, debilitating and rare multisystem disorder.

It is caused by the overproduction of cortisol (a steroid hormone that increases blood sugar levels) by the adrenal glands. This syndrome most commonly affects adults between the ages of 25 and 40.

Mifepristone blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.

Mifepristone is approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery.

It should never be used by pregnant women. Although pregnancy is an extremely rare occurrence in Cushing’s syndrome patients because of the suppressive effect of excess cortisol on female reproductive function.

The most common side effects experienced with mifepristone  are nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite.

Other side effects of mifepristone include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities.

There are no other approved medical treatment for this debilitating form of Cushing’s syndrome.

The US Food and Drug Administration (FDA) warned that patients taking statins may face a “small increased risk” of higher blood-sugar levels and diabetes.

Statins, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). Statins include blockbusters like Lipitor (atorvastatin) – the world’s largest selling drug with annual sales of around $12 billion – and other brands and generic versions like simvastatin, pravastatin and rosuvastatin. The issue has been debated for years with several studies also conducted to research whether there was an increased risk of diabetes by taking statins.

The FDA wants drug companies to add these warnings on labels of these cholesterol-lowering drugs. The drugs regulator here is expected to follow suit within a few months in India too, experts say. There are over a dozen domestic companies including Ranbaxy, Dr Reddy’s, Cipla, Glenmark, Sun Pharma, Lupin, USV, Zydus and Torrent selling generic versions of the drug.

But the FDA said it also wants to assure users that these medications continue to provide an important health benefit of lowering cholesterol.

This randomized controlled, open-label trial compares the effect of bedtime vs morning administration of BP medications on a composite of cardiovascular disease (CVD) outcomes and BP control.

According to Dr. Hermida and colleagues, “treatment at bedtime is the most cost-effective and simplest strategy of successfully achieving the therapeutic goals of adequate asleep BP reduction and preserving or re-establishing the normal 24-hour BP dipping pattern.”

The authors suggest that a potential explanation for the benefit of nighttime treatment may be associated with the effect of nighttime treatment on urinary albumin excretion levels. “We previously demonstrated that urinary albumin excretion was significantly reduced after bedtime, but not morning, treatment with valsartan,” they note. In addition, this reduction was independent of 24-hour changes of BP, but correlated with a decline in BP during sleep.

Refer: J Am Soc Nephrol. Published online October 24, 2011

Indacaterol maleate is a new molecular entity in the β₂-adrenergic agonist class that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. The FDA stated that the long-acting drug is not intended to treat asthma or COPD symptoms that come on fast and strong.

Common adverse effects (> 2% and more common than placebo) are runny nose, cough, sore throat, headache, and nausea.

Indacaterol maleate will carry a boxed warning that, like other long-acting β₂-adrenergic agonists (LABAs), may increase the risk for asthma-related death.

Without use of a long-term asthma control medication, indacaterol maleate and all LABAs are contraindicated in patients with asthma. Indacaterol maleate should not be started in patients with acutely deteriorating COPD, nor should it be used to relieve acute symptoms, which should be managed with concomitant short-acting β₂-agonists.

An FDA advisory panel in March recommended approval of indacaterol maleate after 6 confirmatory clinical trials demonstrated the drug’s safety and efficacy. The trials included nearly 5500 patients 40 years and older with COPD who had smoked at least 1 pack of cigarettes for 10 years and exhibited moderate to severe decreases in lung function.

During the advisory panel meeting, John Walsh, the president of the nonprofit COPD Foundation, said that getting patients to faithfully take twice-daily LABAs is a challenge.

Clinical Use

• The FDA approved indacaterol maleate as a once-daily bronchodilator to prevent COPD symptoms, such as wheezing and breathlessness. Dosage is 75 μg inhaled once daily every day, which should increase compliance relative to twice-daily inhalers. It is not intended for acute relief of COPD exacerbations.
• Common adverse effects seen with use of indacaterol maleate are runny nose, cough, sore throat, headache, and nausea. It will carry a boxed warning that the risk for asthma-related death may be increased. There are several significant drug interactions.
• Indacaterol maleate is pregnancy Category C. It should be used during labor only in those patients in whom the benefits clearly outweigh the risks, and caution is warranted when indacaterol maleate is administered to breast-feeding women. Indacaterol maleate is not indicated for use in children. No adjustment of dosage is warranted in geriatric patients nor in patients with mild and moderate hepatic impairment.

Valproate products are approved to treat seizures and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label for other conditions, particularly other psychiatric conditions.

“FDA has evaluated all available evidence to date, and will be adding information about the risk of lower cognitive test scores to the valproate product labels in the Warnings and Precautions section, the Use in Specific Populations: Pregnancy section, and to the Medication Guides that are being developed for the valproate drug products,” the alert notes.

The FDA previously warned pregnant women and women of childbearing age about valproate use during pregnancy because of known teratogenic effects, and valproate products are assigned to Pregnancy Category D. The FDA also released an Information for Healthcare Professionals communication in December 2009 on the risk for neural tube birth defects after exposure to valproate products during pregnancy.

Their conclusion is based on epidemiologic studies showing that children exposed to valproate in utero tend to score lower on cognitive testing than children exposed to other agents.

The primary study supporting the conclusion is based on the well-known work of Kimford Meador, MD, from Emory University in Atlanta, Georgia, and investigators in the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The FDA has used the data from testing performed when the children were age 3; these results were published in the New England Journal of Medicine in 2009.

 The drug labels now warn that there is an increased risk of being diagnosed with a high-grade prostate cancer while taking these drugs.

 Both drugs are marketed for use in benign prostate hypertrophy and have also been investigated for — but not approved for— prostate cancer prevention in men at high risk.  However, it was in these studies looking at prostate cancer prevention that there was a finding of an increased incidence of high-grade prostate cancer.

The FDA acknowledges that the risk appears to be low but says that practitioners need to be aware of this safety information. The known benefits can then be more accurately weighed against the potential risks when clinicians make a decision about starting or continuing treatment with 5-ARIs.

“[PPIs] and histamine 2 receptor antagonists (H2RAs) are the most popular [acid-suppressive drugs] available, and millions of individuals currently take these medications on a continuous or long-term basis,”

These potent drugs are used to treat various disorders, and indications for long-term maintenance therapy with this drug class continue to expand. The relationship between [acid-suppressive drug] use and bone health remains unclear

The final analyses included 5 case-control studies, 3 nested case-control studies, and 3 cohort studies selected from 1809 articles meeting the initial inclusion criteria. With use vs nonuse of PPIs, the pooled odds ratio (OR) for fracture was 1.29 (95% confidence interval [CI], 1.18 – 1.41) compared with 1.10 (95% CI, 0.99 – 1.23) for use vs nonuse of H2RAs.

Risk for any fracture and for hip fracture was increased with long-term use of PPIs (adjusted OR, 1.30 [95% CI, 1.15 - 1.48]; adjusted OR, 1.34 [95% CI, 1.09 - 1.66], respectively). Vertebral fracture risk was also increased by 54% with PPI use. In contrast, long-term use of H2RA was not significantly associated with fracture risk.

“We found possible evidence linking PPI use to an increased risk of fracture, but no association between H2RA use and fracture risk,” the study authors write. “Widespread use of PPIs with the potential risk of fracture is of great importance to public health. Clinicians should carefully consider their decision to prescribe PPIs for patients already having an elevated risk of fracture because of age or other factors.”

It is not necessary to treat patients to the point of an achlorhydric state to resolve acid reflux symptoms, so we recommend that drug doses be chosen thoughtfully with consideration of what is necessary to achieve desired therapeutic goals,” the study authors conclude.

PPIs have clear benefits in patients that require them, and they should not be denied to patients who are likely to benefit from them,” the editorialists write. “On the other hand, long-term PPI exposure may lead to other unwanted effects and should be reserved for patients likely to benefit from them. They should not be used long-term for undifferentiated dyspepsia, but neither should they be denied for patients with established persistent [gastroesophageal reflux disease], [nonsteroidal anti-inflammatory drugs] risk, and hypersecretory states, while aiming for the lowest effective maintenance dose.”

Ann Fam Med. 2011;9:257-267, 200-202

Refer: Experimental Biology 2011 Annual Meeting: Abstract 349.7.